Gandouling in the Treatment of Wilson's Disease

NCT ID: NCT05305872

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.

Detailed Description

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To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.Test various indicatorsbefore test, 4 weeks, 12 weeks and 24 weeks.

Conditions

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Wilson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group

Gandouling

Group Type EXPERIMENTAL

Gandouling

Intervention Type DRUG

The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.

Control group

Zinc gluconate

Group Type PLACEBO_COMPARATOR

Gandouling

Intervention Type DRUG

The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.

Interventions

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Gandouling

The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.

Intervention Type DRUG

Other Intervention Names

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zinc gluconate

Eligibility Criteria

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Inclusion Criteria

* Comply with the diagnosis of Wilson's disease "Guidelines for Diagnosis and Treatment of Wilson's disease 2021"
* The diagnosis of TCM syndromes complies with the syndrome of phlegm and blood stasis; Other copper-removing drugs
* Patients who have been treated with complexing agents for copper-removing treatment can enter the study after a 2-week washout period
* Age ≥15 years
* Informed consent of patients or legal representatives, And sign the informed consent form.

Exclusion Criteria

* Severe cerebral WD patients: obvious torsion spasm, dysphagia, or bed rest and other severe neurological impairment will interfere with the safety of the subjects (UWDRS Part I neurological function score ≥156 points)
* Severe liver Type WD patients: Decompensated liver cirrhosis or liver cancer, manifested as portal hypertension, ascites, splenomegaly (WBC\<3.0\*109/L, PLT\<50\*1012/L), esophageal varices, gastrointestinal bleeding, Moderate to severe anemia or hepatic encephalopathy; severe liver fibrosis shown by imaging or any laboratory abnormality (UWDRS liver function score ≥ 17 points)
* Moderate to severe depression, recent suicidal thoughts or behavior, Severe psychiatric symptoms (UWDRS Part III Psychiatric Symptom Score ≥ 54 points)
* History of epileptic seizures within 6 months
* Complicated with serious diseases such as brain tumors, brain trauma, blood diseases, Cardiogenic diseases, HIV, etc.
* Nephritis, nephrotic syndrome, or kidney disease stage 3 or more
* Pregnant, planned pregnancy or breastfeeding women
* Cognitive dysfunction MMSE≤26 points
* Those who are currently participating in other clinical trials
* Cannot comply with the follow-up plan
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun Li

OTHER

Sponsor Role lead

Responsible Party

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Jun Li

associate chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jun Li

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Li, Doctor

Role: CONTACT

18788899919

Facility Contacts

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Jun Li, doctor

Role: primary

18788899919

References

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Ding Y, Cao K, Yang W, Hu S, Zhang J, Yang Y, Zhang X. Mapping neurological symptoms and muscle tension representations in impaired gray matter volume of Wilson disease. Front Neurol. 2025 Jun 5;16:1560848. doi: 10.3389/fneur.2025.1560848. eCollection 2025.

Reference Type DERIVED
PMID: 40538652 (View on PubMed)

Other Identifiers

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GWPS

Identifier Type: -

Identifier Source: org_study_id

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